Lisata grants Catalent non-exclusive ADC license with revenue share

Rhea-AI Filing Summary

Lisata Therapeutics entered into a worldwide non-exclusive license agreement with Catalent, Inc. to allow Catalent to use Lisata's iRGD cyclic peptide, certepetide, as an antibody drug conjugate (ADC) payload on Catalent's SMARTag^4 ADC platform. Catalent will assume full responsibility for research, development and commercialization costs, while Lisata is eligible for pre-determined development milestone payments of up to $10.5 million, tiered revenue sharing on future sales and/or partnerships, and a portion of any sublicense consideration. The agreement runs product-by-product and country-by-country until the end of the royalty term and may be terminated for material breach, bankruptcy/insolvency, or by Catalent on 30 days' notice. Catalent granted Lisata a right of first negotiation if Catalent initiates an organized out-licensing process for an asset arising from the collaboration. The company will file the full agreement as an exhibit to its Annual Report for the fiscal year ending December 31, 2025.

Positive

• Non-dilutive monetization via licensing generates potential cash without Lisata funding development
• Contingent upside with up to $10.5 million in development milestones and tiered revenue sharing
• Retained freedom from non-exclusive terms allows Lisata to pursue other partners or uses

Negative

• No guaranteed near-term cash; payments are contingent on milestones and future sales
• Catalent may terminate the agreement with 30 days' notice, creating execution risk for milestone realization
• Royalty reductions and sublicense splits could materially lower Lisata's ultimate revenue share

Insights

Biotech Business Development Lead

TL;DR: Non-exclusive ADC licensing monetizes intellectual property with low near-term capital burden.

The agreement lets Lisata monetize its iRGD peptide through a non-exclusive license while shifting development and commercialization costs to Catalent. The material economic terms are capped milestone receipts of $10.5 million, plus tiered revenue sharing and a share of sublicense proceeds, which create contingent upside without near-term cash outlays.

Key dependencies include Catalent's execution of R&D and commercialization and the structure/timing of any milestone triggers or sublicense deals; those will determine timing and magnitude of receipts through the royalty term. Monitor whether Catalent advances a candidate into clinical work and any announced sublicense deals within the next 12–36 months.

Licensing & IP Attorney

TL;DR: Contract terms preserve Lisata's rights but allow Catalent exit flexibility.

The contract is non-exclusive and preserves Lisata's ability to license to others while granting Catalent commercialization options and a right of first negotiation if Catalent outsources an asset. Termination rights for material breach, insolvency, and Catalent's 30-day termination right are standard and give Catalent flexibility to exit, which could limit long-term guaranteed revenue for Lisata.

Investors should note the product-by-product, country-by-country royalty term structure and the existence of specified royalty reductions; these will materially affect ultimate economics and are disclosed only in the full agreement to be filed with the Annual Report for the fiscal year ending December 31, 2025.

0000320017false00003200172025-10-082025-10-08

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934

October 8, 2025

Date of Report (date of earliest event reported)

LISATA THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware

001-33650

22-2343568

(State or other jurisdiction of incorporation or organization)

(Commission File Number)

(I.R.S. Employer Identification No.)

110 Allen Road, Second Floor, Basking Ridge, NJ 07920

(Address of Principal Executive Offices)(ZipCode)

(908) 842-0100

Registrant's telephone number, including area code

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class			Trading Symbol(s)			Name of each exchange on which registered
Common Stock, par value $0.001 per share			LSTA			The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

☐ Emerging growth company

o If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Item 1.01    Entry into a Material Definitive Agreement.

Non-Exclusive License Agreement

On October 8, 2025, Lisata Therapeutics, Inc. (the “Company”) entered into a worldwide Non-Exclusive License Agreement (the “Non-Exclusive License Agreement” or the “Agreement”) with Catalent, Inc. (“Catalent”), pursuant to which the Company granted to Catalent, on a non-exclusive basis, certain of its intellectual property to exploit use of the Company’s novel iRGD cyclic peptide, certepetide, as an antibody drug conjugate (ADC) payload as part of Catalent’s SMARTag® ADC platform. Under the Agreement, Catalent will assume full responsibility for research, development, and commercialization costs.

Financial Terms. In connection with entering into the Non-Exclusive License Agreement, the Company is eligible to receive pre-determined development milestone payments of up to $10.5 million in the aggregate. The Company is also eligible to receive tiered revenue sharing on future sales and/or partnerships, subject to specified royalty reductions as set forth in the Agreement, as well as a portion of any sublicense consideration received from the grant of any sublicense or similar rights under any of the rights or licenses granted to Catalent under the Agreement. The Agreement will remain in effect until it expires on a product-by-product and country-by-country basis at the end of the royalty term.

Termination. Either party may terminate the Agreement upon the other party’s material breach, subject to specified notice and cure provisions, as well as resulting from the bankruptcy or insolvency of the other party. Catalent may also terminate the Agreement in its entirety at any time by giving the Company at least thirty (30) days prior written notice.

Right of First Negotiation. In connection with the Agreement, Catalent has agreed to grant the Company a right of first negotiation (“ROFN”) for a license, in the event Catalent initiates a specific, organized out-licensing process of an asset resulting from the Agreement.

The foregoing description of the Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Agreement, which the Company intends to file as an exhibit to its Annual Report on Form 10-K for the fiscal year ending December 31, 2025.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

LISATA THERAPEUTICS, INC.

By: /s/ David J. Mazzo            

Name: David J. Mazzo, PhD

Title: President & Chief Executive Officer

Dated: October 8, 2025

FAQ

What did Lisata (LSTA) license to Catalent?

Lisata granted Catalent a worldwide non-exclusive license to use its iRGD cyclic peptide, certepetide, as an ADC payload on Catalent's SMARTag platform.

How much can Lisata receive under the deal (LSTA)?

Lisata is eligible for up to $10.5 million in pre-determined development milestone payments, plus tiered revenue sharing and a portion of sublicense consideration.

Who pays development and commercialization costs under the agreement?

Catalent will assume full responsibility for research, development, and commercialization costs under the agreement.

Can either party terminate the license?

Yes. The agreement may be terminated for material breach or insolvency, and Catalent may terminate the entire agreement with at least 30 days' prior written notice.

Does Lisata retain other licensing options after the deal?

Yes. The license is non-exclusive, so Lisata can license the peptide to others; Catalent granted Lisata a right of first negotiation if Catalent initiates an organized out-licensing process for a resulting asset.